1. Field of the Invention
The invention relates to a guidewire sheath. More particularly, the invention relates to a guidewire sheath having inner and outer sheath members with tips shaped and dimensioned to reduce trauma upon insertion.
2. Description of the Prior Art
In the field of interventional radiology, as well as other medical fields requiring both vascular and non-vascular access to the body, access to the interior of blood vessels must be obtained so that various devices, for example, guidewires, stents, balloons, filters and the like may be introduced into the blood vessel for medical purposes. In general, a device known as a sheath provides for desired access to the interior of the blood vessel.
A sheath generally consists of two concentric plastic tubes that are free to slide easily on each other. In accordance with current sheath designs, the inner and outer plastic tubes are in a “stepped” axial arrangement, that is, the inner plastic tube is longer than the outer plastic tube. The ends of the inner and outer plastic tubes are circular and are in a plane perpendicular to the longitudinal axis of the respective plastic tubes. This design creates a “step” at the ends of the inner and outer plastic tubes. A “step” is formed at the end of the inner plastic tube and the guidewire by the difference in the guidewire outer diameter (OD) and the OD of the end of the inner plastic tube. The length of the “step” is equal to one-half of the difference between the OD at the end of the inner plastic tube and the guidewire OD. A similar “step” is formed at the end of the outer plastic tube. The two “steps” may be of different lengths. In effect, the “steps” are merely radial discontinuities due to the diameter differences at the two “step” locations.
In use, a needle is generally used to obtain access to the interior of the blood vessel. A guidewire is inserted into the blood vessel through the needle and the needle is removed. The two plastic tubes of the sheath are then threaded over the guidewire and forced axially against the flesh of the patient until the tubes are inside the blood vessel. When the inner sheath reaches the patient, a pronounced stop of the insertion is detected by the physician. The stop is due to the radial discontinuity at the “step” between the guidewire OD and the end of the inner plastic tube. To force the inner plastic tube sheath into the hole created by the needle point, a significant axial force must be applied by the physician. The magnitude of the force depends, in part, on the geometry of the “step” and the elastic modulus of the flesh and the plastic tubes. In effect, forcing the sheath into the flesh is akin to creating an interference fit in a pair of cylinders. In an interference fit, a first cylinder is inserted within a second cylinder, wherein the second cylinder has an inner diameter that is slightly smaller than the OD of the first cylinder. Depending on the magnitude of the “step” and the elastic properties of the materials, a substantial axial force is required to produce an interference fit in this manner.
With the foregoing in mind, those skilled in the art will appreciate that current sheath designs have shortcomings that must be addressed. The present invention provides a sheath overcoming the shortcomings of prior sheaths.